This product is an enzyme supplement used to help people who have trouble digesting milk and other dairy products (lactose intolerance). Lactose is a type of sugar found in milk products. Lactase enzyme is normally produced by the body to help break down (digest) lactose. Lactose intolerance occurs when the body produces low amounts of lactase enzyme.

Lactose intolerance can begin at different ages. Infants are not usually affected, but lactose intolerance can affect children as young as 2. It is very common in adults. One way to treat lactose intolerance is to avoid milk products. However, this can result in a lack of important nutrients and vitamins such as calcium, vitamin D, riboflavin, and protein. Some people use lactose-free milk or milk substitutes such as soy or rice milk. Most people with low lactase enzyme levels can tolerate small amounts of milk products at one time (2-4 ounces) and get symptoms only with larger servings (6 ounces or more). Taking lactase enzyme with milk products as directed can help prevent upset stomach, abdominal bloating/cramping, gas, and diarrhea caused by these products.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

This medication usually has very few side effects. If you have any unusual effects from taking this medication, contact your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

rash

itching/swelling (especially of the face/tongue/throat)

severe dizziness

trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any health problems, consult your doctor or pharmacist before using this product.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all products away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised July 2016.

Copyright(c) 2016 First Databank, Inc.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.